Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:41 PM
Ignite Modification Date:
2025-12-24 @ 10:41 PM
NCT ID:
NCT04003935
Eligibility Criteria:
Inclusion Criteria:
* 90 male and female subjects
* age: 50 - 80 years
* post- or peri-menopausal
* Smokers and non-smokers
* BMI 25 to 40 kg/m2
* Dietary Inflammatory Index, DII: 0 to +10
* Fruit and vegetable intake \<4 servings/d
* Adherence to a 6-week "wash-out" period
* Since the intervals between blood drawings are long (6 months), a temporary intake (e.g for a few days, one or two weeks) of some excluded drugs and food supplements does not necessarily mean exclusion from the study
Exclusion Criteria:
* Age \<50 and \>79.9 years
* Dietary Inflammatory Index, DII: - 0.1 to -10
* Subjects with any kind of food allergy or histamine intolerance
* Aversion to stop the intake of nutritional supplements and food, that could interfere with the study outcome
* Food supplements, functional foods and dietetic products with anti-inflammatory or redox-biological relevance like omega-3 fatty acids, plant/herbal extracts/concentrates, vitamin- and mineral supplements
* Fruit and vegetable intake \>3 servings per day
* Hypertension, starting with grade 2 according to the classification of the European Society of Hypertension: systolic blood pressure \> 160 mmHg, diastolic blood pressure \>100 mmHg
* Medication: any anti-inflammatory medication and medication with relevant antioxidant properties, blood pressure lowering medication, psychotropic drugs, immunosuppressives, cytostatics, anticoagulants, contraceptives, diuretics, pain medication
* Clinically relevant infectious disease
* Diabetes mellitus type I and type II
* Auto-immuno diseases
* Any stents and Coronary artery diseases (CAD)
* Cancer patients
* Pregnancy
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
80 Years
Study:
NCT04003935
Study Brief:
Protocol Section:
NCT04003935